Methodological and Ethical Framework
● Did my literature review yield knowledge gaps that my study can help answer?
• Is there a strong rationale for my study?
• Does the gap I am trying to fill make good sense to my colleagues and GME
● Is my idea ethically sound? Are there any unmitigated risks that outweigh potential
benefits or unmanageable conflicts of Interest?
● Does GME have the resources to conduct this type of study design?
● Find details under “How do I know if the research study is possible in the time I have?” to
determine if your research study timeline is feasible.
● Do CMHS facilities, equipment, supplies, and storage meet the needs of my study?
● For prospective studies, will services need to be delivered above and beyond the
standard of care for the patient population enrolled in my study?
• If so, is there time, staff, and funding to cover this?
● Will my study require funding?
● If so, will the $1500 offered through GME for approved study budgets cover all
study costs? If not, I need to consider a different study design.
● You must submit a budget to the ADGME in order to receive support.
● You must receive approval from both the IRB and your Program Director before
your project can begin. The Program Director and ADGME will make the funding
decision, and you may purchase supplies in advance with approval from the
● You MUST have receipts for reimbursement.
• Common covered expenses include: supplies/equipment, participant
compensation for time or costs incurred due to participation. Expenses
that often exceed allowable expenses: clinical coordinator, cost of drugs,
blood draws, any and all imaging not covered by insurance for standard
● GME will provide financial support to attend a regional or national conference if
your abstract or research is accepted for poster or podium presentation.
● GME also covers publication costs up to $1500 in a GME-approved and peerreviewed
● Do I have the technical expertise to complete this study? Does my Research Study Team
have the expertise it needs?
• Prospective drug trials, meta-analyses, and randomized controlled trials are not
● Do I have the right Research Study Team necessary to complete this study with
• Does everyone have time to commit to training and to conduct the study?
● Do I have enough time in my week to commit to doing research well?
● PI Responsibilities before IRB Approval:
• Assemble and Manage Research Study Team. Assure that they have been
properly trained for both study of human subjects (specifically CITI
training on the intranet) and Informed Consenting (if needed)
• Build your budget, if needed.
• If conducting a case report, PI must complete a paper Case Report
application found on the CMHS Institutional Review Board website on the
• Patients need to sign a consent form for publication in a journal.
• Complete eIRB protocol and associated attachments. eIRB submissions will not
be accepted without GME Research Staff approval.
• Use the What IRB Documents to Use When document to prepare your
● For PI Responsibilities after IRB approval see “My study got approved.” → “Not
that my study was approved, what’s next?”
● Are the data I need available within the CMHS EMR?
• We have multiple EMRs and each has a separate IT analyst. Our current EMR
systems only collect discrete data fields (e.g., ICD codes, labs, demographic
details). It will not include elements from surgical reports, patient histories,
medications, nor patient vitals.
• If you need data from the EMR, you will need to contact the GME Research Team
for assistance in completing the IT Request Form.
• Will I need any data not already collected in the EMR? If so, who will collect it and
• How will data be stored and protected? (Including: consent forms, study
• You are not allowed to store PHI on your personal computers at home.
• Will data need to be sent to/received from a source external to CMHS?
● If so, who will collect it and how?
● Data being sent in email needs to be encrypted using #Secure
• Enter #SECURE# in the subject field for manual encryption
• Open Outlook Web Access and compose your email
message as you normally would.
• When you have finished composing the text of your email
message, click the PGP Tray icon.
• Select Current Window, then click Encrypt, Sign, or Encrypt
& Sign. The PGP Desktop -Key Selection Dialog screen is
• Drag or double-click users to add user keys to the
• Click OK and enter the passphrase for your key when
Recruitment and Consenting
● Is the potential participant pool large enough?
• Does CMHS have the patient population for this study to be completed in a timely
manner? You might chat with GME Research Staff who can connect you with
CMHS data on your study population to make more targeted projections on
• If in doubt, can you remove and analyze any criterion/comorbidity separately
while still maintaining the integrity of the research question, scope of the project,
and scientific value?
● Do I have adequate time to recruit?
• Think through how many subjects would need to be enrolled per
month/week/day to gather enough data to complete your study within a timely
• Are there additional/other recruitment sites that could help funnel patients your
• Is the recruitment site appropriate? Do patients have the medical decision
making capacity to process the opportunity fully and provide fully informed
• Is there anything that could be done to improve the environment?
• Do you need to translate your consent form into additional languages? The GME
department has translation services available for approved projects.
• Does your Research Study Team have what it needs to screen, recruit and
• Is the flyer/script recruiters are using clear?
• Is the time burden for the participant commensurate with the potential benefits
of study participation?
• Is compensation offered and if so, is it in proportion to the commitment?